Monopar Therapeutics Inc. — Q3 2022 Form 10-Q
Reporting period: Three and nine months ended September 30, 2022; filed November 10, 2022. Monopar is a clinical-stage biopharmaceutical company developing four oncology-focused candidates. It reported no product revenue and remains dependent on external financing and potential collaborations.
Financial performance and position
| Metric | Q3 2022 | Q3 2021 | Nine months 2022 | Nine months 2021 |
|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $0 |
| Research and development | $1.732 million | $1.827 million | $5.489 million | $4.511 million |
| General and administrative | $0.675 million | $0.632 million | $2.139 million | $1.936 million |
| Total operating expenses | $2.407 million | $2.459 million | $7.628 million | $6.446 million |
| Net loss | $2.400 million | $2.458 million | $7.619 million | $6.423 million |
| Basic and diluted net loss per share | $0.19 | $0.20 | $0.60 | $0.52 |
- Cash and liquidity: Cash and cash equivalents were $14.316 million at September 30, 2022, down $5.987 million from December 31, 2021. Current assets were $14.372 million and current liabilities $1.914 million.
- Cash flow: Operating activities used $5.927 million in the first nine months, versus $5.285 million in the comparable 2021 period. Financing activities used $0.106 million, versus providing $10.887 million in 2021, primarily reflecting no stock sales in 2022 compared with ATM proceeds in 2021.
- Debt and liabilities: The filing reports no borrowings. Total liabilities were $1.935 million, including $68,651 in operating lease liabilities. The company had an accumulated deficit of $48.908 million and stockholders’ equity of $12.510 million.
- Margins: Not applicable because the company had no revenue.
Changes versus the prior comparable period
- Q3 net loss narrowed by approximately $59,000, as operating expenses declined about $52,000. Nine-month net loss widened by approximately $1.197 million, with operating expenses increasing $1.182 million.
- Nine-month R&D costs rose $978,000, mainly from Validive clinical and manufacturing costs and camsirubicin trial costs; G&A rose $204,000, primarily due to salaries and benefits.
- Cash fell during the 2022 nine-month period, while cash increased in 2021, when the company raised $10.925 million net through its ATM program. It made no stock sales under its new $4.870 million ATM agreement through September 30, 2022.
- Shares outstanding increased to 12,855,735 at September 30, 2022, from 12,598,125 at year-end 2021.
Outlook, management commentary, and risks
- Management estimated that available cash would fund planned operations at least through November 30, 2023, and reported no substantial doubt about the company’s ability to continue as a going concern. This estimate is not assurance that current cash will fund completion of the development programs.
- Additional funding is needed to complete the Validive VOICE program, including a possible confirmatory Phase 3 trial, and to advance other candidates. The company planned to pursue financing or partnerships within the next 12 months; failure to obtain funds or a suitable partner could force termination of one or more programs.
- Validive: The Phase 2b/3 VOICE trial was enrolling in the U.S. and Europe; 73 sites were activated as of October 31, 2022. An interim-analysis go/no-go decision was anticipated in Q1 2023. Completion of the program could require millions or tens of millions of dollars, depending on partnership arrangements.
- Camsirubicin: The Phase 1b dose-escalation trial was dosing at its fourth dose level. The company reported no drug-related cardiotoxicity to date at the current level and anticipated topline results by November 2023, but said higher dose levels could extend the trial and require additional funding.
- Other programs: MNPR-101 radioimmunotherapeutic and diagnostic candidates were being developed with NorthStar under a 50/50 collaboration; MNPR-202 remained in preclinical development with a research collaboration in Singapore.
- Risks include clinical and regulatory uncertainty, patient enrollment and third-party manufacturing or trial execution, the need for additional capital, possible dilution or unfavorable financing terms, competition, inflation, geopolitical disruption, and potential COVID-19 effects. The company also disclosed possible Validive milestone payments to Onxeo of up to $108 million and MNPR-101 milestones to XOMA of up to $14.925 million if specified milestones are achieved; none had been triggered as of September 30, 2022.
- No material legal claims were reported. Disclosure controls and procedures were assessed as effective, with no material change in internal control over financial reporting during the quarter.
Important facts for investors to verify
- Whether the company can raise sufficient capital or secure partnerships, and how financing terms may affect dilution and program priorities.
- VOICE enrollment, interim-analysis timing and results, and the funding needed to complete the full clinical program.
- Camsirubicin dose-escalation progress, safety findings, trial duration and the timing of topline results.
- Actual cash burn and runway compared with management’s estimate through November 2023, including the effect of planned development spending.
- Progress and funding requirements for the NorthStar collaboration and the MNPR-202 preclinical program.